Acetaminophen
- Product NDC
- 68196-031
- Requested package NDC
- 68196-031-06
- 11-digit product format
- 681960031
- Labeler code
- 68196
- Product ID
- 68196-031_6a06c9ee-2b77-4501-ac01-900cd595d597
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sam's West Inc
- Application
- M013
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-11-14
- Substance
- ACETAMINOPHEN
- Active strength
- 500 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Acetaminophen
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 500 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 362O9ITL9D | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198440 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1098d0e7-8202-4018-a2d2-b0c80ee58b56 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68196-031-06 | Acetaminophen | 600 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 600 | 2 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| BackAid | ACETAMINOPHEN, CAFFEINE | Kobayashi Healthcare International, Inc. | 25db6bb5-96b6-4be1-e063-6294a90a2300 | 2025-10-21 | Warnings | M013 |
| M-PAP | ACETAMINOPHEN | Method Pharmaceuticals, LLC | 1539dc44-15a0-153b-e063-6294a90a9d45 | 2025-10-21 | Warnings | M013 |
| M-PAP | ACETAMINOPHEN | Method Pharmaceuticals, LLC | 3d1bb61c-15db-4eba-aba9-cfbcbc7b30e0 | 2025-10-21 | Warnings | M013 |
| Walgreens Antacid Pain Relief Extra Strength | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Walgreens | b60df498-07db-500b-e053-2a95a90aff6a | 2025-10-17 | Warnings | M013 |
| Equate Effervescent Antacid and Pain Relief | ASPIRIN, CITRIC ACID, SODIUM BICARBONATE | Walmart | 6271b34b-55a0-40a8-e053-2a91aa0acb22 | 2025-10-17 | Warnings, Adverse reactions | M013 |
| Xesso Neo | BENZOCAINE | PREMIUM NATURAL COSMETICS INC | 163f32cd-4e51-950a-e063-6394a90a4816 | 2025-10-17 | Warnings | M013 |
| Menstrual Complete Maximum Strength | ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE | CHAIN DRUG MARKETING ASSOCIATION INC | 913d8bdb-7644-464c-b9a6-55387ff12059 | 2025-10-17 | Warnings | M013 |
| Alka-Seltzer Hangover Relief | ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE | Bayer HealthCare LLC. | dc235b06-999e-221d-e053-2a95a90a0ce1 | 2025-10-16 | Warnings | M013 |
| Aspirin 81mg | ASPIRIN ENTERIC COATED TABLETS 81MG | VITANE PHARMACEUTICALS, INC | 41386de5-5857-efab-e063-6294a90afd9c | 2025-10-15 | Warnings | M013 |
| Aspirin 81mg | ASPIRIN ENTERIC COATED TABLETS 81MG | VITANE PHARMACEUTICALS, INC | 4138d4c0-baa5-1f20-e063-6394a90a788f | 2025-10-15 | Warnings | M013 |
| TEXACLEAR PAIN RELIEVER | CAFFEINE, CHOLINE SALICYLATE | GM Pharmaceuticals, INC | 065bd10c-3bcf-486f-a49c-40544127007f | 2025-10-15 | Warnings | M013 |
| ACETAMINOPHEN 500 MG | ACETAMINOPHEN | ASCLEMED USA INC. | db8e6702-88ac-4db2-9dd8-7d0ed997c2b5 | 2025-10-14 | Warnings | M013 |
| Pain Reliever Extra Strength | ACETAMINOPHEN | Walgreen Company | fa33f6ef-522b-4630-9716-92371d9cd24a | 2025-10-14 | Warnings | M013 |
| acetaminophen | ACETAMINOPHEN | Rite Aid Corporation | a8bb4f45-7a1a-4bf7-92ca-3afd508032f3 | 2025-10-09 | Warnings | M013 |
| Pain Reliever | ACETAMINOPHEN | Health Pharma USA LLC | b15a7dcb-f143-4aea-8850-d0aacbf709b6 | 2025-10-09 | Warnings | M013 |
| Acetaminophen | ACETAMINOPHEN | PD-Rx Pharmaceuticals, Inc. | 3f96aeb1-a533-4d36-9a1f-62fc094b6754 | 2025-10-08 | Warnings | M013 |
| Headache Relief Extra Strength | ACETAMINOPHEN, ASPIRIN, CAFFEINE | Walgreens | f2eb9575-d527-44c7-aa5e-efabfd9a0278 | 2025-10-07 | Warnings | M013 |
| Acetaminophen PM Extra Strength | ACETAMINOPHEN, DIPHENHYDRAMINE HCL | CHAIN DRUG MARKETING ASSOCIATION INC | bbc704e5-79f6-4c72-846b-cc30c5c43cb4 | 2025-10-07 | Warnings | M013 |
| Aspirin Enteric Coated | ASPIRIN | CHAIN DRUG MARKETING ASSOCIATION INC | f1ce15a3-9824-4eb5-910a-39078165f385 | 2025-10-07 | Warnings | M013 |
| BupropiDex | DEXTROMETHORPHAN HYDROBROMIDE | DXM Pharmacuetical, Inc. | 90cc9bcd-7891-4324-a1f4-f6df7a0457e0 | 2025-10-06 | Warnings | M013 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198440 | acetaminophen 500 MG Oral Tablet | PSN | 1098d0e7-8202-4018-a2d2-b0c80ee58b56 | 2 |
| 198440 | acetaminophen 500 MG Oral Tablet | SCD | 1098d0e7-8202-4018-a2d2-b0c80ee58b56 | 2 |
| 198440 | APAP 500 MG Oral Tablet | SY | 1098d0e7-8202-4018-a2d2-b0c80ee58b56 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 68196-031-06 | 68196003106 | 600 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68196-031-06) | 2025-11-14 | No | No | Current |